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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M EBV AMPLIFICATION REAGENT KIT; NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)

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ABBOTT MOLECULAR, INC. ALINITY M EBV AMPLIFICATION REAGENT KIT; NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV) Back to Search Results
Model Number 09N43-095
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2023
Event Type  malfunction  
Manufacturer Narrative
Elevated complaint investigation will be initiated.
 
Event Description
The customer reported discrepant (false detected) alinity ebv results with lower limit of quantification (lloq).Sample id, alinity result, date, mayo result : (b)(6).Mayo results were generated using an alternative platform (roche molecular).There was no impact to patient management for the sample ids listed above.Mayo results were released to provider.The reported event was considered false detected.
 
Manufacturer Narrative
The ticket was reported for discrepant results (false positive) below lower limit of quantification (
 
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Brand Name
ALINITY M EBV AMPLIFICATION REAGENT KIT
Type of Device
NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV)
Manufacturer (Section D)
ABBOTT MOLECULAR, INC.
1300 e. touhy ave.
des plaines IL 60018 3315
Manufacturer (Section G)
ABBOTT MOLECULAR, INC.
1300 e. touhy ave.
des plaines IL 60018 3315
Manufacturer Contact
albert chianello
1300 e. touhy ave.
des plaines, IL 60018-3315
2242064064
MDR Report Key16450192
MDR Text Key310436415
Report Number3005248192-2023-00118
Device Sequence Number1
Product Code QLX
UDI-Device Identifier00884999049505
UDI-Public00884999049505
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212778
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date04/06/2023
Device Model Number09N43-095
Device Catalogue Number09N43-95
Device Lot Number381017
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/30/2023
Initial Date FDA Received02/27/2023
Supplement Dates Manufacturer Received05/12/2023
Supplement Dates FDA Received05/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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